Active Pregnancy. Mental and Emotional Health Care to Pregnant Woman During and After Coronavirus (COVID-19)

Mental Health Wellness Clinical Trial

— GESTACTIVE  

Official title:

Active Pregnancy. Mental and Emotional Health Care to Pregnant Woman During and After COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05295264
• Other study ID #: Gestactive2022
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2022
• Est. completion date: December 30, 2025

Study information

• Verified date: June 2022
• Source: Universidad Politecnica de Madrid
• Contact: Cristina Silva-Jose, Msc
• Phone: 662556019
• Email: cristina.silva.jose[@]upm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The complex process of pregnancy and childbirth can determine the future health of mother and child. It is the only vital process that involves the modification of practically all of a woman's body systems in order to sustain fetal life. In this sense, it is essential to ensure adequate functioning of all maternal physiological, mental and emotional mechanisms that facilitate fetal growth and development. Complications in any of these health domains and functions may contribute to pathologies and complications that have a detrimental impact on maternal and newborn health. Pregnancy could be a vulnerable period for women, especially regarding mental and emotional illnesses, which are more likely to manifest during this time compared to other periods of their life. In this sense, a high prevalence of prenatal stress, anxiety and depression exists, which are associated with downstream newborn complications as well. Depressive symptoms such as sadness, decreased interest in everyday activities, reduced energy and concentration are generated by the aforementioned gestational lability, these symptoms would appear (mostly) at the beginning of the pregnancy. Feelings of being overwhelmed, uneasiness, threat or imminent danger, uncertainty, difficulty in making decisions, obsessive thoughts could be caused by prenatal anxiety. According to scientific literature, the consequences of mental and emotional disturbances during pregnancy go beyond the gestational period and affect mother, fetus, newborn, and even child development, including complications such as preterm delivery, prolonged and more instrumental labor, low birth weight, pre-term birth, infant's physical and cognitive developmental delay, and the poor mother-infant relationship.

Description:

COVID-19. Risks associated with an inactive pregnancy: The impact of COVID-19 has generated a global crisis never before experienced, which affects physiological, emotional, mental, and social factors for all population groups, including those who are pregnant with important related risks. The complications associated with confinement (no group support, reduced mobility, the distance between people, etc.), significantly affects the lifestyle of pregnant individuals and potentially remove one of the basic recommendations established by the international scientific community: a physically active lifestyle. Scientific evidence confirms that engaging in an unhealthy lifestyle during pregnancy, including inactivity, enhances the risk of chronic disease for both mother and fetus. In fact, the growing epidemic of sedentary behavior affects pregnancy and childbirth with adverse pre, peri, and postnatal outcomes. Unfortunately, the situation caused by COVID-19 could further exacerbate sedentary behavior and its associated complications for pregnant women. Current Status: Before the COVID-19 pandemic, the range of prenatal mental and emotional alterations was close to 15-30%, the prevalence being particularly high in low- and middle-income countries. However, the new social and economic situation generated by the COVID-19 pandemic has raised these values significantly, in this sense 37% reported clinically relevant symptoms of depression and 57% of pregnant women experienced symptoms of anxiety. This means that the pandemic has negatively affected the mental and emotional health of pregnant women, and consequently of future generations. It is necessary (urgent) to intervene right now with preventive policies and alternatives. The difficulty and associated (maternal/fetal) risks of pharmacological treatment of mental and emotional illnesses during pregnancy, requires the scientific search for new alternatives, especially aimed at the prevention of these pathologies. There are important lifestyle recommendations promoted by the scientific community about establishing elements that ensure a healthy pregnancy. However, a small percentage of pregnant women meet global healthy lifestyle guidelines. In fact, the scientific literature reports an increase of perinatal disorders, for example, a high percentage of women continue to gain excessive weight during pregnancy in spite of mentioned health recommendations, and this in turn also increases the risk for other complications. There are no official estimates of healthcare costs that these complications generate but obviously, we speculate significant amounts. Worldwide, 80% of pregnant women or (or maybe more) don´t achieve the minimum weekly amount of 150 minutes of moderate physical activity intensity. In Spain, this inactivity is similar to other countries, with approximately 19.7% of women achieving the American College of Obstetricians and Gynecologists (ACOG) recommendations to be active weekly during pregnancy. Physical exercise as a preventive factor: Given this complex problem, it is necessary (urgent) to find non-invasive prevention mechanisms to benefit the wellbeing of the mother and her child, taking into account that pregnancy predisposes the woman to a significant change in lifestyle. As substantiated by scientific evidence, physical exercise during pregnancy does not cause adverse effects on the mother and fetus. Indeed, physical exercise during pregnancy may prevent chronic disease risk in the mother and fetus. Although the scientific literature is not entirely conclusive, many studies show the positive influence of a physical activity program during pregnancy on maternal mental and emotional status (even with better benefits if it´s supervised); this could be a good approach to maintain healthy mental wellbeing. GESTACTIVE will examine the effects of a supervised moderate exercise program during pregnancy as a preventive tool for mental and emotional distress, as well as associated complications. The results of this proposal will contribute to the improvement of the quality of life of pregnant women and thus the promotion of health of future generations. Hypothesis Aerobic, moderate, and supervised exercise during pregnancy can be an efficient element of the prevention of mental and emotional alterations that the situation generated by COVID-19 causes to the healthy pregnant population and their children. Objective Examine the influence of a supervised aerobic exercise program during pregnancy, in non-face-to-face and face-to-face ways, on the prevention of maternal mental and emotional health, fetal, newborn, and infant outcomes during the pandemic state and in the near future. Material and Methods: - Study design. A randomized clinical trial (RCT) will be carried out, not masked with healthy pregnant women, giving rise to two study groups: exercise group (EG), pregnant women participating in a regular program of supervised physical exercise and control group ( CG), pregnant women who receive normal obstetric monitoring of their pregnancy, including recommendations regarding dietary-nutritional factors, as well as the benefits of an active pregnancy. All selected pregnant women will sign an Informed Consent before participating in the study. Women randomly assigned to the CG received general advice from their health care provider about the positive effects of physical activity. Participants in the CG had their usual visits with health care providers during pregnancy, which were equal to the exercise group. Women were not discouraged from exercising on their own. However, women in the CG were asked about their exercise once each trimester using a "Decision Algorithm" (by telephone). Intervention General characteristics of the physical exercise program: - The minimum adherence required will be 80% of the total sessions. - Onset: gestational week 9-11, immediately after the first prenatal ultrasound, in order to rule out Obstetric Contraindications for physical exercise. - End: gestational week 38-39. - Frequency: 3 weekly sessions, various possibilities will be offered at different times from which the pregnant woman can choose, in order to promote work and family conciliation. Basic Considerations: a, All the activities carried out will be aerobic. b. Avoid working positions in which areas normally overloaded by pregnancy are further affected. c. The work corresponding to flexibility will be carried out always bearing in mind that these are pregnant women, this forces us once again not to include forced operating positions in the exercises or to excessively maintain the stretching times in each area. d. An adequate fluid intake will be maintained before and after the activity. e. Also as a general rule and to eliminate potential risks, the following will be avoided: - Activities that include the Valsalva maneuver. - High ambient temperatures or very humid environments in order to avoid hyperthermia (body temperature higher than 38º C). - Sudden movements. - Positions of extreme muscular tension. Structure: All sessions will begin with a warm-up of 7-8 minutes composed of mild movements and joint mobility of upper and lower limbs exercises. Then a central part of 35-40 minutes, four types of activities will be included (aerobic work, muscle strengthening, coordination/balance tasks, pelvic floor exercises), finally a section of flexibility, relaxation and final talk (comments and sharing) will be performed (12-15 minutes). Below we offer a greater detail of each part: I. Warm-up-General activation. Displacements varied without impact activities (avoiding jumps, falls). Mild work of mobility of the main joints. II. Aerobic section. Exercise to increase intensity up to moderate activities, play with sports equipment (balls, ropes, pikes), or choreographies of different musical styles. III. Muscle strengthening, general toning exercises of the whole body: lower part (calf, quadriceps, hamstrings, adductors, abductors), upper part (abdominal, pectoral, shoulders, paravertebral musculature). Also exercises for the most weakened and needy muscle groups during pregnancy, the aim is to avoid muscular decompensation. IV. Coordination and balance exercises: simple tasks of eye-hand and eye-foot coordination with sports equipment, as well as body axis balance exercises. V. Strengthening the pelvic floor muscles, Kegel exercises will be applied and is basically composed of contractions (slow and fast) of the different structures of the pelvic floor musculature. VI. Relaxing section during 7-8 minutes, aiming to gradually lower the intensity of work with flexibility-stretching and relaxation exercises. VII. Final Talk. This part is intended for pregnant women to express clearly and openly the sensations and perceptions experienced during the session. The reflection of each participant on the effect of physical practice is sought, not only in the physical or physiological aspect but also in the psychic and emotional section. The exchange of impressions between the pregnant women enhances the role of a correctly designed and conducted physical exercise program, as a social mobile of maintenance and improvement of the quality of life of the pregnant woman.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 30, 2025
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pregnant women fulfilling the following criteria: >18 years old, singleton pregnancies and planning management and delivery at the research hospitals, and also do not participate in any other program of supervised physical exercise. Exclusion Criteria: Women with absolute contraindications. Women with relative contraindications need permission from obstetric care providers prior to participation:

Absolute contraindications to exercise:

• Ruptured membranes.
• Premature labor.
• Unexplained persistent vaginal bleeding.
• Placenta praevia after 28 weeks gestation.
• Pre-eclampsia.
• Incompetent cervix.
• Intrauterine growth restriction.
• High-order multiple pregnancies (eg, triplets).
• Uncontrolled type I diabetes.
• Uncontrolled hypertension.
• Uncontrolled thyroid disease.
• Other serious cardiovascular, respiratory, or systemic disorders.

Relative contraindications to exercise:

• Recurrent pregnancy loss.
• Gestational hypertension.
• A history of spontaneous preterm birth.
• Mild/moderate cardiovascular or respiratory disease.
• Symptomatic anemia.
• Malnutrition.
• Eating disorder.
• Twin pregnancy after the 28th week.
• Other significant medical conditions. Women in the CG were asked about their exercise once each trimester using a "Decision Algorithm" and those who are excessively actives were excluded.

Related Conditions & MeSH terms

• Emotional Problem
• Mental Health Wellness

Intervention

Other:
• Moderate exercise program
Exercise program All sessions will begin with a warm-up of 7-8 minutes composed of mild movements and joint mobility of upper and lower limbs exercises. Then a central part of 35-40 minutes, four types of activities will be included (aerobic work, muscle strengthening, coordination/balance tasks, pelvic floor exercises), finally a section of flexibility, relaxation, and final talk (comments and sharing) will be performed (12-15 minutes). Healthy lifestyle advise This intervention consists of providing guidelines and videos with advice on healthy habits throughout the pregnancy process. This type of content will be related to daily physical activity, food recommendations, and fundamental exercises to perform during pregnancy.

Locations

Country	Name	City	State
Spain	Facultad de Ciencias de la Actividad Física y el Deporte - INEF	Madrid

Sponsors (7)

Lead Sponsor	Collaborator
Universidad Politecnica de Madrid	Clinica Zuatzu, Hospital Clinic of Barcelona, Hospital Severo Ochoa, Hospital Universitario de Torrejón de Ardoz, Hospital Vall d'Hebron, Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (28)

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Sánchez-Polán M, Franco E, Silva-José C, Gil-Ares J, Pérez-Tejero J, Barakat R, Refoyo I. Exercise During Pregnancy and Prenatal Depression: A Systematic Review and Meta-Analysis. Front Physiol. 2021 Jun 28;12:640024. doi: 10.3389/fphys.2021.640024. eCollection 2021. — View Citation

Sánchez-Polán M, Silva-Jose C, Franco E, Nagpal TS, Gil-Ares J, Lili Q, Barakat R, Refoyo I. Prenatal Anxiety and Exercise. Systematic Review and Meta-Analysis. J Clin Med. 2021 Nov 24;10(23). pii: 5501. doi: 10.3390/jcm10235501. Review. — View Citation

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recovery of pelvic floor muscles ultrasound	analyze the diameter and thickness of muscles in the perineal area and their interrelationship with physical exercise patterns	6 months
Other	Maternal habits of physical activity - Pregnancy Physical Activity Questionnaire (PPAQ)	analyze with a questionnaire how it varies during and after pregnancy	12 months
Other	Pregestational maternal patterns	analyze sociodemographic and behavioral habits like (smoking, alcoholism, previous illness, COVID-19, parity, occupation, previous miscarriage...)	9 months
Other	Coronavirus disease	analyze the coronavirus condition during pregnancy and its interrelationship with other variables	9 months
Primary	Prenatal depression (CES-D)	analyze with a questionnaire the variability during pregnancy (Likert scale 0-3)	9 months
Primary	Prenatal anxiety, State-Trait Anxiety Inventory (STAI)	analyze with a questionnaire the value and its interrelationship with physical exercise patterns (Likert scale 0-3)	9 months
Primary	Prenatal stress, Perceived Stress Scale (PSS)	analyze with a questionnaire the value and its interrelationship with physical exercise patterns(Likert scale 0-3)	9 months
Primary	Postnatal depression, Edinburgh Postnatal Depression Scale (EPDS).	analyze with a questionnaire the value and its interrelationship with physical exercise during pregnancy(Likert scale 0-5)	6 months
Primary	Postnatal anxiety, State-Trait Anxiety Inventory (STAI)	analyze with a questionnaire the value and its interrelationship with physical exercise patterns (Likert scale 0-3)	6 months
Primary	Postnatal stress, PSS (Perceived Stress Scale)	analyze with a questionnaire the value and its interrelationship with physical exercise patterns(Likert scale 0-5; higher scores mean a worse outcome)	6 months
Secondary	Maternal weight gain	analyze the increase during pregnancy	9 months
Secondary	Blood pressure	analyze how it varies during pregnancy	9 months
Secondary	O'Sullivan test (OGTT)	analyze the value and its interrelationship with physical exercise patterns	1 month
Secondary	Urinary Incontinence Questionnaire (ICIQ-SF)	analyze with a questionnaire the value and its interrelationship with physical exercise patterns (different measures in the questionnaire)(Likert scale 0-5; higher scores mean a worse outcome)	9 months
Secondary	Behavior of Fetal Heart Rate	analyze variability during pregnancy	3 months
Secondary	Gestational age	analyze the value and its interrelationship with physical exercise patterns	9 months
Secondary	Type of delivery (Vaginal, instrumental or cesarean)	analyze whether women have had a vaginal, instrumental, or cesarean delivery and its interrelationship with physical exercise patterns	1 month
Secondary	Duration of labor	analyze the value and its interrelationship with physical exercise patterns	1 month
Secondary	Birthweight	analyze the value and its interrelationship with physical exercise patterns	1 month
Secondary	Child's weight	analyze the value and its interrelationship with physical exercise patterns during pregnancy	24 months
Secondary	Child's height	analyze the value and its interrelationship with physical exercise patterns during pregnancy	24 months
Secondary	Mental assessment of the child (depression questionnaire adapted to childhood)	analyze the value and its interrelationship with physical exercise patterns during pregnancy (Likert scale 0-3)	24 months
Secondary	Psychomotor behavior of the child	analyze some variables (sitting, crawling, standing, walking, holding objects...) and its relationship with maternal exercise	24 months
Secondary	Maternal pains during pregnancy (headache, back pain, pelvic pain, paravertebral, scapular, etc.)	analyze the value and its interrelationship with physical exercise patterns	9 months
Secondary	Fetal growth and development	analyze the value and its interrelationship with physical exercise patterns	9 months
Secondary	Delivery tears	analyze the value and its interrelationship with physical exercise patterns	1 month
Secondary	Performing episiotomy during childbirth	analyze the appearance (descriptive: yes/no) and its interrelationship with physical exercise patterns	1 month
Secondary	Apgar Score	analyze the value and its interrelationship with physical exercise patterns (1 to 10)	1 month
Secondary	Birth length	analyze the value and its interrelationship with physical exercise patterns	1 month
Secondary	Head circumference	analyze the value and its interrelationship with physical exercise patterns	1 month
Secondary	Landau reflexes test	analyze the value and its interrelationship with physical exercise pattern	1 month
Secondary	Neonatal intensive care unit (NICU)	analyze the number of admissions and its interrelationship with physical exercise patterns	1 month
Secondary	Postpartum recovery of pre-pregnancy weight	analyze how it varies during postpartum period	12 months
Secondary	Umbilical cord Ph	analyze the value and its interrelationship with physical exercise patterns	1 month
Secondary	Fetal development	analyze variables (estimated fetal weight, Fetal cardiac function, fetal measures, uterine arteries...) by ultrasound	9 months, once a trimester
Secondary	Carotid intima-media thickness (CIMT)	Measurement of carotid intima-media thickness (CIMT) with B-mode ultrasound is a noninvasive, sensitive, and reproducible technique for identifying and quantifying subclinical vascular disease and for evaluating cardiovascular disease (CVD) risk.	9 months
Secondary	Maternal sleep habits	analyze with Pittsburgh´s sleep quality index (Likert scale 0-5; higher scores mean a worse outcome)	9 months
Secondary	Maternal body self-perception	analyze using Ben-Toby Walker Body Attitude Questionnaire (Likert scale 0-5; higher scores mean a worse outcome)	9 months
Secondary	Newborn sleep habits	analyze using Brief Infant Sleep Questionnaire (Likert scale 0-5; higher scores mean a worse outcome)	24 months
Secondary	Perception of health status - Short Form 36 health scale	analyze the value and its interrelationship with physical exercise patterns (Likert scale 0-5; higher scores mean a better outcome)	9 months
Secondary	Placental angiogenic factors	placental growth factor (PIGF)	measured at 24-25 weeks and at 34-35 weeks
Secondary	Placental angiogenic factors	soluble fms-like tyrosinekinase-1 (sFlt1)	measured at 24-25 weeks and at 34-35 weeks
Secondary	Lipidic profile	( Total Cholesterol, LDL-Cholesterol, HDL- Cholesterol, Tryglicerids)	measured at 24-25 weeks and at 34-35 weeks